Eu Ivdd Eu Ivd Annex 2 List A On The Market 🇩🇪 Germany

ABO Set (Anti-A (1/512), Anti-B (1/512), Anti-D (1/128)), 3x10ml/Plastic Pack

Atlas Medical GmbH · 🇩🇪 Germany
Devices (same UDI-DI)
1
Certificates
2
Countries
0
Notified Bodies
2

Basic Information

Primary DI
04260658555994
Basic UDI-DI Code
B-04260658555994
Reference
8.02.47.0.0030
Device Types
None provided
Regulation
Eu Ivdd
Classification
Eu Ivd Annex 2 List A
Status
On The Market
Manufacturer
Atlas Medical GmbH

Additional Description

Atlas Anti-A, Anti-B and Anti-AB reagents (here under referred to as ABO reagents) are used for qualitative in-vitro determination of human blood groups of the ABO system to determine the blood type. Anti-D reagent is used for the qualitative determination of Rhesus factor on human blood groups.

CND Nomenclature Codes

Code Description
W0103030199 ABO TYPING TESTS - OTHER

Certificates

Type Number
IVDD Annex IV (excluding sections 4, 6) 33540
IVDD Annex IV Section 4 33544

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